NCT01393665

Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease

Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: PharmaKing · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	PENNEL capsule	hard capsule DDB 25mg \& GO 50mg in cap .......... 1 capsule 1 or 2 capsule, T.I.D
DRUG	Placebo	Placebo

Timeline

• Start date: 1996-12-01
• Primary completion: 1997-05-01
• Completion: 1997-10-01
• First posted: 2011-07-13
• Last updated: 2011-07-13

Locations

2 sites across 1 country: South Korea